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NCT06619301 · ClinicalTrials.gov registry record · Phase 3

RCT Glargine vs NPH for Treatment of DM in Pregnancy

A Phase 3 study of Type 2 Diabetes Mellitus (T2DM) and Diabetes Mellitus in Pregnancy, sponsored by Loyola University.

Recruiting
Registry status
Phase 3
Development phase
160
Enrollment target
1
Study location

NCT06619301 is a Phase 3 study of Type 2 Diabetes Mellitus (T2DM) and Diabetes Mellitus in Pregnancy that is actively recruiting participants, run by Loyola University. The registered enrollment target is 160 participants, below the 515-participant average among 24 other Type 2 Diabetes Mellitus (T2DM) trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06619301, a Phase 3 study of Type 2 Diabetes Mellitus (T2DM) and Diabetes Mellitus in Pregnancy, is actively recruiting participants, sponsored by Loyola University.

RECRUITING
Registry status
Phase 3
Development phase
160 participants
Enrollment target
1
Study location

Study Summary

We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin. Outside of pregnancy, NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. Detemir has been well studied in pregnancy and found to be noninferior to NPH. Unfortunately, glargine has not been as well studied in pregnancy. Thus, with this study we want to compare glargine and NPH. The purpose of this study is to compare two different forms of insulin (Glargine and NPH) that we regularly use to manage diabetes mellitus in pregnancy.

Conditions Studied

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus in Pregnancy Gestational Diabetes Mellitus, Class A2

Interventions

  • DRUG Insulin glargine
  • DRUG insulin NPH

Study Locations (1)

Illinois

  • Loyola University Medical Center - Maywood

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2024-04-01
Est. Completion 2027-01-01
Phase Phase 3

Sponsor

Loyola University

92 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06619301

The ClinicalTrials.gov registry entry for NCT06619301 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 515-participant average among 24 other Type 2 Diabetes Mellitus (T2DM) trials with a reported enrollment target (69% lower). The listed sponsor is Loyola University, which has 92 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Type 2 Diabetes Mellitus (T2DM) appearing as the primary indexed condition, and to 2 interventions - of which Insulin glargine is the first listed.

NCT06619301 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT06619301 about?

NCT06619301 is a clinical study titled "RCT Glargine vs NPH for Treatment of DM in Pregnancy". We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, gla...

What is the current status of trial NCT06619301?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2024-04-01. Estimated completion is 2027-01-01.

What conditions does trial NCT06619301 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus (T2DM), Diabetes Mellitus in Pregnancy, Gestational Diabetes Mellitus, Class A2.

What interventions are being tested in trial NCT06619301?

The interventions under investigation include: Insulin glargine (DRUG), insulin NPH (DRUG).

Who is sponsoring clinical trial NCT06619301?

This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06619301 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.